WARNING: The prolonged administration of procainamide often leads to the development of a positive anti-nuclear antibody (ANA) test, with or without symptoms of a lupus erythematosus-like syndrome. If a positive ANA titer develops, the benefit versus risks of continued procainamide therapy should be assessed.
Procainamide Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of procainamide hydrochloride in water for injection. Each milliliter of the 2 mL vial contains procainamide hydrochloride 500 mg; methylparaben 1 mg and sodium metabisulfite 1.8 mg added in water for injection. Each milliliter of the 10 mL vial contains procainamide hydrochloride 100 mg; methylparaben 1 mg and sodium metabisulfite 0.8 mg added in water for injection. In both formulations, the solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.0 (4.0 to 6.0). Headspace nitrogen gassed. Procainamide Hydrochloride Injection is intended for intravenous or intramuscular administration. Procainamide hydrochloride, a Group 1A cardiac antiarrhythmic drug, is ρ-amino-N-[2-(diethylamino) ethyl] benzamide mono-hydrochloride.
Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of procainamide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (see WARNINGS and Boxed Warning.)
Published Studies Related to Procainamide
Levofloxacin and ciprofloxacin decrease procainamide and N-acetylprocainamide renal clearances. [2005.04]
Ten healthy adults participated in a randomized, crossover drug interaction study testing procainamide only, procainamide plus levofloxacin, and procainamide plus ciprofloxacin.
Clinical Trials Related to Procainamide
Certain People With Atrial Fibrillation May Have Changes on Ecg When Given Procainamide That May be Related to a Genetic Difference [Recruiting]
The purpose of this study is to look for a similarity in people's genes that may help
understand which people could benefit from certain drugs for the treatment of atrial
Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia [Recruiting]
The purpose of this study is to determine whether intravenous amiodarone has less cardiac
significant adverse events compared to intravenous procainamide in the acute treatment of
haemodynamically well tolerated wide QRS tachycardia, the majority of them of probably
Sexual and Urological Rehabilitation to Men Operated for Prostate Cancer and Their Partners [Recruiting]
Today prostate cancer (PC) treatment with curative intent is primarily surgical removal of
the prostate gland (prostatectomy) which may be associated with immediate and long lasting
erectile dysfunction and decline in urinary function. Besides these physical late effects
patients operated for PC have a twofold increased risk for depression up to ten years after
the diagnosis. To reduce these late effects affecting both patient and partner the
investigators have developed a sexual and urological intervention (PROCAN). The intervention
is based on epidemiological data, evidence from previous clinical trials, a feasibility
study and qualitative explorations among PC patients and partners. The investigators hereby
suggest the conduction of a randomized controlled trial to test the effect of the PROCAN
intervention on urological and sexual dysfunction, couples adjustment and quality of life.
Results of the proposed trial may provide clinicians and decision makers with the evidence
needed to optimize rehabilitation after PC.
Chemical vs Electrical Cardioversion for Emergency Department Patients With Acute Atrial Fibrillation [Recruiting]
Atrial fibrillation (AF) is the most common type of irregular heartbeat in emergency
department (ED) patients. If the irregular heartbeat has been present for less than 48
hours, there is a chance that emergency treatment can convert the heartbeat into normal
There are currently two options for accomplishing this; both are widely and safely used in
EDs. Each has its advantages and disadvantages. This study will compare the two methods. (1)
Patients are given an intravenous medication called procainamide; this converts patients
into a normal heart rhythm around 50% of the time. (2) Patients are sedated (put to sleep
with a general anesthetic) for about ten minutes, while an electrical current is conducted
across the chest; this converts patients into a normal heart rhythm around 90% of the time.
Procainamide can cause low blood pressure in about 10% of patients; this is usually
corrected by administering intravenous fluids. Sedation can cause low blood pressure in
about 10% of patients, and breathing trouble in about 10% of patients; this is usually
corrected by administering intravenous fluids, and administering more oxygen, respectively.
In thousands of patients studied around the world, there does not appear to have been a
reported stroke or death as a result of these procedures.
A physician will choose one method, but if it fails, will move to the next method. There are
thus two options. (1) Chemical conversion, followed by electrical conversion; and (2)
Electrical cardioversion, followed by chemical cardioversion. These options both have a 90%+
chance of converting AF into a normal heart rhythm. However, the investigators believe that
an electrical-chemical sequence will be faster than a chemical-electrical sequence, while
both will be equally safe.
If patients agree to take part in the study, they will be randomized to one of the two
options. They will have their breathing, oxygen levels, blood pressure, and heartbeat
monitored for their entire ED stay.
The investigators plan to enrol 86 patients at five hospitals over the course of about one
year. The primary outcome of ED length-of-stay, as well as secondary outcomes, such as
conversion to normal rhythm, and adverse events (such as trouble breathing or low blood
pressure) will be documented. In addition, an investigator will contact you at three and
thirty days after your visit to make sure that there are no problems. Importantly, although
the principal and site investigators will be aware of the primary outcome, attending
emergency physicians who actually provide patient care will NOT be aware of the primary
outcome--otherwise this could bias patient management.
When the study is finished, the results will be given to the writing committee merely as the
"A" and "B" arms, and not specified as either the "chemical-first" or "electrical-first"
arms. The writing committee will compose two manuscripts, (1) assuming that "A" is the
"chemical-first" arm and "B" the "electrical-first" arm, and (2) assuming that "A" is the
"electrical-first"arm, and "B" the "chemical-first" arm. After both manuscripts have been
approved by all authors, the blinding will be removed and only the correct manuscript
submitted for publication.
Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias [Recruiting]
The study evaluates 3 different populations:
It is an open, randomized, parallel-group study comparing the effectiveness of intravenous
(iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of :
1. recent-onset atrial fibrillation versus iv flecainide
2. sustained monomorphous ventricular tachycardia versus iv procainamide
The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline
versus iv flecainide in the diagnosis of Brugada syndrome
Page last updated: 2006-01-31